More attention needed to conflicts
presented by institutional relationshipsStudy suggests that some medical
schools' policies are incomplete

BOSTON - February 12, 2008 - A new study indicates that many
U.S. medical schools do not have policies that govern conflicts
of interest related to financial relationships the institutions
have with public or private companies. In the Feb. 13 Journal
of the American Medical Association, researchers from Massachusetts
General Hospital (MGH) and the Association
of American Medical Colleges (AAMC) report that, while about
70 percent of responding medical schools have policies related to
the financial interests of key institutional officials, only about
than a third have policies addressing the interests held by the
institution itself.

"Thirty eight percent of schools have implemented policies
covering potential conflicts arising from their own financial interests
in research, but almost two thirds still have not." says Eric
G. Campbell, PhD, of the MGH Institute
for Health Policy, the study's principal investigator. "This
raises questions about the potential impact of institutional conflicts
of interests on the missions of academic medical centers."

Federal regulations regarding potential conflicts of interest in
government-funded research have been in place since 1995 but specifically
address conflicts involving individual investigators. Subsequently
the AAMC and the Association of American Universities recommended
the adoption of specific policies for institutional conflicts of
interest - defined as financial interests of the institution itself
or of major institutional officials that may affect or appear to
affect the conduct of research. This study was designed to explore
the extent to which institutional conflict of interest policies
have been adopted.

The researchers note that some recent reports have suggested the
process of developing and implementing these policies has been difficult,
given the complexity of many types of institutional relationships.
The current study is the first systematic national examination of
the adoption and scope of medical schools' institutional conflict
of interest policies. During 2006 the team sent questionnaires regarding
such policies to the deans of 125 U.S. medical schools. Representatives
from 86 schools completed and returned the surveys, a response rate
of 69 percent.

Among responding medical schools, 38 percent reported having an
institutional conflict of interest policy, and 37 percent reported
that such policies were in development. About 70 percent reported
having policies addressing the interests of senior or mid-level
institutional officers. More than 80 percent have policies addressing
the interests of members of Institutional Review Boards (IRBs),
which are charged with ensuring that clinical studies uphold patient
rights and follow ethical guidelines; and two-thirds have policies
related to the institution's governing boards.

More than 90 percent of responding medical schools have organizational
structures that separate the handling of the institution's investment
portfolio from management responsibility for the research program.
The majority of respondents also restrict investment officials from
serving on IRBs or evaluating potential conflicts of interest.

"The survey's results raise questions about whether the national
associations have given enough attention to the mechanics and complexity
of implementing these policies," says Susan Ehringhaus, JD,
of the AAMC, the report's lead author. "The results also suggest
that institutions may need some additional support in addressing
this issue in the future and that institutional conflicts of interest
have not received the emphasis and attention given to individual
financial conflicts."

Campbell adds, "The next step is to figure out how effective
are the policies that have been put into place - whether some work
better than others - and what impact, if any, the lack of these
policies has on the research, educational and patient care mission
of academic health centers." Additional co-authors of the report
- which was funded by the Greenwall Foundation - are Joel S. Weissman,
PhD, and Sandra Feibelmann, MPH, MGH-IHP; Jacqueline Sears, MPH,
AAMC; and Susan Dorr Goold, MD, University of Michigan.

Massachusetts General Hospital, established in 1811, is the original
and largest teaching hospital of Harvard Medical School. The MGH
conducts the largest hospital-based research program in the United
States, with an annual research budget of more than $500 million
and major research centers in AIDS, cardiovascular research, cancer,
computational and integrative biology, cutaneous biology, human
genetics, medical imaging, neurodegenerative disorders, regenerative
medicine, systems biology, transplantation biology and photomedicine.